Mucus DM Extended Release
- Product NDC
- 59726-833
- Requested package NDC
- 59726-833-20
- 11-digit product format
- 597260833
- Labeler code
- 59726
- Product ID
- 59726-833_703080fe-ba91-4794-9e29-23506d5aa657
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide and Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- ANDA209692
- Marketing category
- ANDA
- Marketing start
- 2019-01-01
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59726-833 | 59726-833-20 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 59726-833 | 59726-833-20 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 59726-833 | 59726-833-20 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 59726-833 | 59726-833-20 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ||
| A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 782e0a99824c… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59726-833-20 | 2023-04-19 | C162847 | 48780-1 | d6a99b39-3692-a426-e053-dadaa90af4c2 | Drug Facts |
| 59726-833-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3692-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 3850544d-0d25-429e-98a9-5c4ad6cfd222 | 2026-07-14 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 6d454e89-59ce-40dc-b0d2-3330a7df519f | 2026-04-15 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 344de7bb-de3b-4c15-a920-72d94e5e0e9f | 2026-03-18 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 59c338a0-8dc9-43a7-b8df-c26ae475def3 | 2026-03-18 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | e24fd894-5dee-4f46-aafa-fbf9f0b166fd | 2026-02-10 | Warnings | 209692 ANDA209692 |
| Maximum Strength Guaifenesin DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rugby Laboratories | 2c9515f8-3120-4dbb-a7fc-d89fc5727148 | 2026-02-10 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rugby Laboratories | 69cd399a-0103-4543-bb06-c7cccffe9cc4 | 2026-02-10 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | P & L Development, LLC | a397799d-46a6-447b-9498-17436d218e29 | 2026-01-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2426bf76-19bf-4bfd-8f9e-3b348e4b5641 | 2025-11-11 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | ebc1a915-f643-4878-9d7a-67a9c6a26b20 | 2025-10-30 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | b60d1cc6-086c-4483-a101-c5f8d6000969 | 2025-10-29 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Walgreens | be5ab61a-abd6-4dee-9607-2f1e2c47b2dc | 2025-08-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Walgreens | 11310cf8-ea34-47a2-b4d7-fe1131fef462 | 2025-08-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 8467474f-6278-47d9-8228-451d08ddf983 | 2025-08-20 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 035693ed-d720-430b-98f5-fe4b5dec5db6 | 2025-08-20 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | d6aae1a1-0ab9-4b26-9f62-b8761014bb35 | 2025-06-30 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | ATLANTIC BIOLOGICALS CORP. | 308f50dd-e8d6-0264-e063-6394a90afa68 | 2025-06-27 | Warnings | 209692 ANDA209692 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amneal Pharmaceuticals LLC | 5760a828-1c28-4272-a7b7-ac98466aa294 | 2024-10-25 | Warnings | 209692 ANDA209692 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amneal Pharmaceuticals LLC | cfdbcdb0-531a-4d95-ac5d-64d6d034b252 | 2024-10-25 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | H E B | 20df2ffe-5281-4cd6-adb3-3a3d28788ef6 | 2024-08-02 | Warnings | 209692 ANDA209692 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59726-833-20 | 59726083320 | 20 BLISTER PACK in 1 CARTON (59726-833-20) > 1 TABLET in 1 BLISTER PACK | 20 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |